Handheld personal data assistant (PDA) with a medical device and method of using the same

ABSTRACT

A medical device module for use in a system with a remote programmer and/or a personal data assistant (PDA) with at least one medical device includes a housing, at least one medical device and a processor. The housing is adapted to couple with the PDA. The at least one medical device interface is coupled to the housing for interfacing with the at least one medical device. The processor is coupled to the at least one medical device interface to process data from the at least one medical device. The processor is also capable of interfacing with the PDA.

RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/429,385,filed May 5, 2003, which is a continuation of U.S. patent applicationSer. No. 09/935,827, filed Aug. 23, 2001—now U.S. Pat. No. 6,641,533,which is a continuation of U.S. patent application Ser. No. 09/487,423filed Jan. 20, 2000—now U.S. Pat. No. 6,558,320, which is a continuationof U.S. patent application Ser. No. 09/334,858 filed Jun. 16, 1999—nowU.S. Pat. No. 6,554,798, that claims priority on U.S. ProvisionalApplication Ser. No. 60/096,994 filed Aug. 18, 1998, a continuation ofU.S. patent application Ser. No. 09/377,472 filed Aug. 19, 1999 thatclaims priority on U.S. Provisional Application Ser. No. 60/103,812filed Oct. 8, 1998, a continuation of U.S. patent application Ser. No.09/334,996 filed Jun. 17, 1999, and a continuation of U.S. patentapplication Ser. No. 09/246,661 filed Feb. 5, 1999—now U.S. Pat. No.6,248,067, all of which are herein specifically incorporated byreference in their entireties.

FIELD OF THE INVENTION

This invention relates to remote programmers and/or handheld personaldata assistants (PDA) for use with medical devices and, in particularembodiments, to a PDA that includes a medical device to facilitatetesting and monitoring of a patient's condition with coordination ofdata management and programming through the PDA.

BACKGROUND OF THE INVENTION

Over the years, bodily characteristics have been determined by obtaininga sample of bodily fluid. For example, diabetics often test for bloodglucose levels with a blood glucose meter. Traditional blood glucosedeterminations have utilized a painful finger stick using a lancet towithdraw a small blood sample that is used by the blood glucose meter.This results in discomfort from the lancet as it contacts nerves in thesubcutaneous tissue. To obtain a measure of control or information on adiabetic's condition, several finger sticks and tests are required eachday (8 or more such tests a day are not uncommon). The pain of lancingand the cumulative discomfort from multiple needle sticks is a strongreason why patients fail to comply with a medical testing regimen usedto determine a change in characteristic over a period of time. Inaddition, these blood glucose meters are only designed to provide dataat discrete points, and even with multiple tests a day, do not providecontinuous data to show the variations in the characteristic betweentesting times.

A variety of implantable electrochemical sensors for use with monitorshave been developed for detecting and/or quantifying specific agents orcompositions in a patient's blood. For instance, glucose sensors havebeen developed for use in obtaining an indication of blood glucoselevels in a diabetic patient. Such readings are useful in monitoringand/or adjusting a treatment regimen which typically includes theregular administration of insulin to the patient. Thus, blood glucosereadings from the monitor improve medical therapies with semi-automatedmedication infusion pumps of the external type, as generally describedin U.S. Pat. Nos. 4,562,751; 4,678,408; and 4,685,903; or automatedimplantable medication infusion pumps, as generally described in U.S.Pat. No. 4,573,994, which are herein incorporated by reference. Typicalthin film sensors are described in commonly assigned U.S. Pat. Nos.5,390,671; 5,391,250; 5,482,473; and 5,586,553 which are incorporated byreference herein. See also U.S. Pat. No. 5,299,571. However, themonitors and electrochemical sensors often require calibration usingreadings obtained from blood glucose meters to augment and adjust fordrift over time. Thus, although the monitors and electrochemical sensorsprovide more accurate trend information, a separate blood glucose meteris still often required.

A user must often carry multiple devices to test different aspects ofthe same value or characteristic. For instance, the a user would need ablood glucose meter and blood glucose monitor. In addition, individualsare also carrying other electronic devices, such as an infusion device,cellular telephones, personal entertainment systems (such as radios,cassette players, CD players, or the like). They may also include smallpersonal computers, personal data assistants (PDAs) or the like. Thus,users often carry a large number of separate electronic devices, whichcan be cumbersome and inconvenient to handle.

SUMMARY OF THE DISCLOSURE

It is an object of an embodiment of the present invention to provide animproved remote programmer and/or personal data assistant (PDA) thatincludes a characteristic monitor and/or a characteristic meter, whichobviates for practical purposes, the above mentioned limitations.

According to an embodiment of the present invention a remote programmerfor interfacing with at least one medical device includes at least onemedical device module, at least one processor, a housing, at least oneinput/output port, at least one display, at least one button, at leastone audio indication device and at least one portable power supply. Theat least one medical device module is operatively coupled with theremote programmer and includes at least one medical device interface tointerface with the at least one medical device. The at least oneprocessor is to interface with the remote programmer and is coupled tothe at least one medical device interface to process data from the atleast one medical device. The housing is adapted to contain the medicaldevice module and the at least one processor. The at least oneinput/output port is for communicating with the at least one medicaldevice. The at least one display includes at least one touch screenelement to interface with the at least one of the at least one processorand the at least one medical device. The at least one button is tointerface with at least one of the at least one processor and the atleast one medical device, and the at least one audio indication deviceis coupled to the at least one processor to provide an audio indication.The at least one portable power supply is contained within the housingof the remote programmer to provide power to at least one of the atleast one processor and the at least one medical device. In stillfurther embodiments, the at least one medical device is an infusiondevice, a characteristic monitor, a characteristic meter, an analytesensor patch and/or more than one medical device. In other embodiments,the remote programmer is personal data assistant (PDA).

In particular embodiments, the at least one medical device module has aseparate housing that is adapted to couple with the housing of theremote programmer. In other embodiments, the at least one medical deviceis a characteristic sensor that produces a signal indicative of acharacteristic of a user, and further includes a second characteristicdetermining device. The second characteristic determining device iswithin the housing for receiving and testing an analyte to determine thequantity of the analyte independently of the at least one characteristicsensor. The at least one medical device interface is a sensor receiverto receive sensor data signals produced from the at least onecharacteristic sensor, and the at least one processor is coupled to thesensor receiver and the second characteristic determining device toprocess the determined quantity of the analyte from the secondcharacteristic determining device and the sensor data signals from theat least one characteristic sensor. In further embodiments, the at leastone characteristic sensor is remotely located from the at least onemedical device module, and the sensor receiver receives the sensor datasignals as wireless signals from the remotely located at least onecharacteristic sensor.

In other embodiments, the remote programmer further includes atransmitter coupled to the at least one processor and the input/outputport for transmitting the processed sensor data signals to another datareceiving device. In additional embodiments, the at least one medicaldevice module uses the display of the remote programmer to show thedetermined quantity of the analyte from the second characteristicdetermining device and the processed sensor data signals from the atleast one characteristic sensor. Also, the at least one processormonitors the sensor data signals from the sensor receiver to determinewhen the second characteristic determining device is to be used toperform calibration of the sensor data signals. In yet otherembodiments, the remote programmer further includes at least one memoryto store the determined quantity of the analyte from the secondcharacteristic determining device and the processed sensor data signalsfrom the at least one characteristic sensor. In particular embodiments,the sensor data signals are received by the sensor receivercontinuously, near continuously or intermittently. In other embodiments,the second characteristic determining device is a second medical devicemodule that utilizes a second characteristic sensor. In theseembodiments, the determined quantity of the analyte from the secondcharacteristic determining device is determined continuously, nearcontinuously or intermittently.

In further embodiments of the present invention, the second medicaldevice module and the second characteristic sensor use a differentsensing technology from that used by the at least one medical devicemodule and the characteristic sensor. In addition, the secondcharacteristic determining device utilizes a discrete sample todetermine the quantity of the analyte. Also, the second characteristicdetermining device may utilize a test strip to analyze the sample todetermine the quantity of the analyte.

In yet further embodiments, the remote programmer further includes atransmitter coupled to the at least one processor and the input/outputport. The the at least one processor further includes the ability toprogram other medical devices, and the transmitter transmits a programto the other medical devices. In particular embodiments, the transmittertransmits through a relay device between the transmitter and a remotelylocated processing device. In some embodiments, the relay deviceincreases a maximum distance by amplifying the processed sensor datasignals from the transmitter to be received by the remotely locatedprocessing device. In other embodiments, the relay device enables theremotely located processing device to be located in a different roomthan the transmitter. While in other embodiments, the relay deviceincludes a telecommunications device, and when the transmitter generatesan alarm the telecommunications device transmits the alarm to a remotelylocated receiving station. Further embodiments of the remote programmerinclude a data receiver, and the data receiver receives programinstructions from other processing devices.

In additional embodiments, a medical device module for use in a systemwith the at least one medical device and the remote programmer includesa module housing, the at least one medical device interface and at leastone module processor. The module housing is adapted to couple with thehousing of the remote programmer. The at least one medical deviceinterface is coupled to the module housing for interfacing with the atleast one medical device. The at least one module processor is coupledto the at least one medical device interface to process data from the atleast one medical device, and wherein the at least one module processoris capable of interfacing with the at least one processor of the remoteprogrammer.

In more embodiments, the at least one medical device is a characteristicsensor that produces a signal indicative of a characteristic of a user,and the medical device module further includes a second characteristicdetermining device. The second characteristic determining device iswithin the housing for receiving and testing an analyte to determine thequantity of the analyte independently of the at least one characteristicsensor. The the at least one medical device interface is a sensorreceiver to receive sensor data signals produced from the at least onecharacteristic sensor, and the at least one module processor is coupledto the sensor receiver and the second characteristic determining deviceto process the determined quantity of the analyte from the secondcharacteristic determining device and the sensor data signals from theat least one characteristic sensor.

According to a further embodiment of the present invention, a medicaldevice module for use in a system with a personal data assistant (PDA)with at least one medical device includes a housing, at least onemedical device and a processor. The housing is adapted to couple withthe PDA. The at least one medical device interface is coupled to thehousing for interfacing with the at least one medical device. Theprocessor is coupled to the at least one medical device interface toprocess data from the at least one medical device. The processor is alsocapable of interfacing with the PDA.

In preferred embodiments, the at least one medical device is acharacteristic sensor that produces a signal indicative of acharacteristic of a user, and the medical device module further includesa second characteristic determining device within the housing forreceiving and testing an analyte to determine the quantity of theanalyte independently of the at least one characteristic sensor. The atleast one medical device interface is a sensor receiver to receivesensor data signals produced from the at least one characteristicsensor. The processor is coupled to the sensor receiver and the secondcharacteristic determining device to process the determined quantity ofthe analyte from the second characteristic determining device and thesensor data signals from the at least one characteristic sensor.

In particular embodiments, the at least one characteristic sensor isremotely located from the medical device module, and the sensor receiverreceives the sensor data signals as wireless signals from the remotelylocated at least one characteristic sensor. In other embodiments, themedical device module further includes a transmitter coupled to theprocessor for transmitting the processed sensor data signals to anotherdata receiving device. In additional embodiments, the medical devicemodule uses a display of the PDA to show the determined quantity of theanalyte from the second characteristic determining device and theprocessed sensor data signals from the at least one characteristicsensor. In further embodiments, the processor monitors the sensor datasignals from the sensor receiver to determine when the secondcharacteristic determining device is to be used to perform calibrationof the sensor data signals.

In other embodiments, the medical device module further includes amemory to store the determined quantity of the analyte from the secondcharacteristic determining device and the processed sensor data signalsfrom the at least one characteristic sensor. In still other embodiments,the sensor data signals are received by the sensor receivercontinuously, near continuously or intermittently.

In yet another embodiments, the second characteristic determining deviceis a second medical device module that utilizes a second characteristicsensor. In these embodiments, the determined quantity of the analytefrom the second characteristic determining device is determinedcontinuously, near continuously or intermittently. In a furtherembodiment, the second medical device module and the secondcharacteristic sensor use a different sensing technology from that usedby the at least one medical device module and the characteristic sensor.

In still yet another embodiment of the present invention, the secondcharacteristic determining device utilizes a discrete sample todetermine the quantity of the analyte. In further embodiments, thesecond characteristic determining device utilizes a test strip toanalyze the sample to determine the quantity of the analyte. In stillfurther embodiments, the at least one medical device is an infusiondevice, an analyte sensor patch and/or more than one medical device.

Still other preferred embodiments of the present invention are directedto a personal data assistant (PDA) for interfacing with at least onemedical devices described above. In these embodiments, the medicaldevice module operatively couples with the PDA and the PDA includes ahousing adapted to receive the medical device module.

Further preferred embodiments of the present invention are directed to amedical device module for use in a system with a personal data assistant(PDA) with at least one characteristic sensor that produces a signalindicative of a characteristic of a user. The medical device moduleincludes a housing, a test strip receptacle, a sensor receiver and aprocessor. The housing is adapted to operatively couple with the PDA.The test strip receptacle for receiving and testing a test strip exposedto an analyte to determine the quantity of the analyte. The sensorreceiver is for receiving sensor data signals produced from the at leastone characteristic sensor. The processor is coupled to the sensorreceiver and the test strip receptacle to process the determinedquantity of the analyte from the test strip receptacle and the sensordata signals from the at least one characteristic sensor, and theprocessor is capable of interfacing with the PDA.

In particular embodiments, the at least one characteristic sensor isremotely located from the medical device module, and wherein the sensorreceiver receives the sensor data signals as wireless signals from theremotely located at least one characteristic sensor. In otherembodiments, the medical device module further includes a transmittercoupled to the processor for transmitting the processed sensor datasignals to another data receiving device. Preferably, the transmittertransmits the processed sensor signals by radio frequencies. Inadditional embodiments, the transmitter transmits through a relay devicebetween the transmitter and a remotely located processing device.Preferably, the relay device increases a maximum distance by amplifyingthe processed sensor data signals from the transmitter to be received bythe remotely located processing device. Alternatively, the relay deviceenables the remotely located processing device to be located in adifferent room than the transmitter. In other alternative embodiments,the relay device includes a telecommunications device, and when thetransmitter generates an alarm the telecommunications device transmitsthe alarm to a remotely located receiving station.

In further embodiments, the processor of the medical device modulefurther includes the ability to program other medical devices, andwherein the transmitter transmits a program to the other medicaldevices. In still other embodiments, the medical device module furtherincludes a data receiver, and the data receiver receives programinstructions from other processing devices.

In yet another embodiment, the medical device module uses a display onthe PDA to show the determined quantity of the analyte from the teststrip receptacle and the processed sensor data signals from the at leastone characteristic sensor. In still other embodiments, the processor ofthe medical device module the sensor data signals from the sensorreceiver to determine when the test receptacle is to be used to performcalibration of the sensor data signals.

Additional embodiments of the medical device module further include amemory to store the determined quantity of the analyte from the teststrip receptacle and the processed sensor data signals from the at leastone characteristic sensor. In particular embodiments, the sensor datasignals are received by the sensor receiver continuously, nearcontinuously or intermittently.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings which illustrate, by way of example, variousfeatures of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the several figures.

FIG. 1 is a perspective view of a system using a handheld data assistant(PDA) and computer in accordance with an embodiment of the presentinvention.

FIG. 2 is a perspective view of a PDA with a medical device module inaccordance with an embodiment of the present invention.

FIG. 3 is a bottom plan view of the PDA and medical device shown in FIG.2.

FIG. 4 is a perspective view of the PDA including a medical devicemodule that includes a characteristic monitor and characteristic meterand that interfaces with a telemetered characteristic monitortransmitter in accordance with a first embodiment of the presentinvention.

FIG. 5 is a block diagram of the medical device module that includes thecharacteristic monitor and the characteristic meter shown in FIG. 4.

FIG. 6 is a perspective view of the medical device module that includesthe characteristic meter and characteristic monitor that interfaces witha telemetered characteristic monitor transmitter in accordance with theembodiment of FIGS. 4 and 5.

FIG. 7 is a perspective view of a PDA including a medical device modulethat includes a characteristic meter, characteristic monitor thatinterfaces with a telemetered characteristic monitor transmitter, and aninfusion device in accordance with a second embodiment of the presentinvention.

FIG. 8 is a perspective view of the medical device module that includesthe characteristic meter and characteristic monitor that interfaces witha telemetered characteristic monitor transmitter and interfaces with theinfusion device in accordance with the embodiment of FIG. 7.

FIG. 9 is a simplified block diagram of a telemetered characteristicmonitor transmitter and medical device module in accordance with a thirdembodiment of the present invention.

FIG. 10 is a simplified block diagram of a telemetered characteristicmonitor transmitter and medical device module system in accordance witha fourth embodiment of the present invention.

FIG. 11 is a perspective view of a medical device module that interfaceswith a telemetered characteristic monitor transmitter in accordance witha fifth embodiment of the present invention.

FIG. 12 is a perspective view of a medical device module that interfaceswith a characteristic meter in accordance with a sixth embodiment of thepresent invention.

FIG. 13 is a perspective view of a medical device module that interfaceswith an infusion device, telemetered characteristic monitor transmitterand a characteristic meter in accordance with a seventh embodiment ofthe present invention.

FIG. 14 is a perspective view of a medical device module that includes acharacteristic meter and interfaces with an infusion device inaccordance with an eighth embodiment of the present invention.

FIG. 15 is a perspective view of a medical device module that includes acharacteristic meter in accordance with a ninth embodiment of thepresent invention.

FIG. 16 is a perspective view of a medical device module that interfaceswith an infusion device in accordance with a tenth embodiment of thepresent invention.

FIG. 17 is a perspective view of a medical device module that interfaceswith an implantable medical device in accordance with a tenth embodimentof the present invention.

FIG. 18 is a perspective view of a medical device module that includes ainput jack for a wired connection with a medical device in accordancewith an eleventh embodiment of the present invention.

FIG. 19 is a perspective view of a medical device module that interfaceswith an implantable analyte sensing patch in accordance with a twelfthembodiment of the present invention.

FIG. 20 is a perspective view of a medical device module that includescontacts for interfacing with a medical device in accordance with athirteenth embodiment of the present invention.

FIG. 21 is a simplified block diagram of an external infusion device andsystem in accordance with an embodiment of the present invention.

FIG. 22 is a perspective view of an external infusion device and systemin accordance with an embodiment of the present invention.

FIG. 23 is a top perspective view of an RF programmer in accordance withan embodiment of the present invention.

FIG. 24 is a top perspective view of a remote commander in accordancewith another embodiment of the present invention.

FIG. 25 is a simplified diagram of an external infusion device andsystem in accordance with another embodiment of the present invention.

FIG. 26 is a simplified block diagram of an external infusion device andsystem in accordance with still another embodiment of the presentinvention.

FIG. 27 is a simplified block diagram of an external infusion device andsystem in accordance with yet another embodiment of the presentinvention.

FIG. 28 is a simplified block diagram of a telemetered characteristicmonitor transmitter and characteristic monitor in accordance withanother embodiment of the present invention.

FIG. 29 is a simplified block diagram of a telemetered characteristicmonitor transmitter and characteristic monitor system in accordance withstill another embodiment of the present invention.

FIG. 30 is a simplified block diagram of a characteristic monitor with acharacteristic meter in accordance with a first embodiment of thepresent invention.

FIG. 31 is a perspective view of a characteristic monitor with acharacteristic meter in accordance with a first embodiment of thepresent invention.

FIG. 32 is a perspective view of a characteristic monitor with acharacteristic meter in accordance with a second embodiment of thepresent invention.

FIG. 33 is a perspective view of a characteristic monitor with acharacteristic meter for use with a telemetered glucose sensor and aninfusion pump in accordance with a third embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings for purposes of illustration, the invention isembodied in a remote programmer and/or a handheld personal dataassistant (PDA) that includes a medical device module for interfacingwith a medical device. In preferred embodiments, medical device moduleinterfaces with a characteristic monitor that obtains data from atelemetered characteristic monitor transmitter connected to a sensor setthat determines body characteristics on a continuous, near continuous orintermittent basis. In further embodiments of the present invention, themedical device module interfaces with a characteristic meter forobtaining discrete measurements. In particular embodiments, themeasurements received from the characteristic meter can be utilized by acharacteristic monitor for calibration and/or data analysis andverification. In preferred embodiments, the characteristic monitorinterfaces with a telemetered characteristic monitor transmitter thatuses a sensor set and is for determining glucose levels in the bloodand/or bodily fluids of the user. Preferably, the characteristic meteris primarily adapted for use with test strips that use a blood sample todetermine glucose levels. However, other embodiments of thecharacteristic meter may use other testing structures, such as liquidsamples placed in a receptacle, or the like, or test strips that usesamples from other fluids, such as interstitial fluid, spinal fluid,saliva, urine, tears, sweat, or the like. However, it will be recognizedthat further embodiments of the invention may be used to interface withother telemetered characteristic monitors transmitters and/or meters todetermine the levels of other agents, characteristics or compositions,such as hormones, cholesterol, medication concentrations, viral loads(e.g., HIV), or the like. In preferred embodiments, the characteristicmonitor and sensor are primarily adapted for use with subcutaneous humantissue. However, still further embodiments may be placed in other typesof tissue, such as muscle, lymph, organ tissue, veins, arteries or thelike, and used in animal tissue. Other embodiments of the presentinvention may interface with other medical devices, such as pacemakers,implanted analyte sensor patches, infusion devices, telemetry devices,or the like.

As illustrated in FIG. 21, preferred embodiments of the infusion device1010 include a remote RF programmer 1012, a carbohydrate (or bolus)calculator 1014 and/or a vibration alarm 1016. The RF programmer 1012and carbohydrate calculator 1014 communicate with a processor 1018contained in a housing 1020 of the infusion device 1010. The processor1018 is used to run programs and control the infusion device 1010, andis connected to an internal memory device 1022 that stores programs,history data, user defined information and parameters. In preferredembodiments, the memory device is a ROM and DRAM; however, inalternative embodiments, the memory device 1022 may include other memorystorage devices such as RAM, EPROM, dynamic storage such as flashmemory, energy efficient hard-drive, or the like. In preferredembodiments, the infusion device 1010 is an external infusion pump thatis programmed through a keypad 1024 (including keys 1108, 1110, 1112 and1114) on the housing 1020 or by commands received from the RF programmer1012 through a transmitter/receiver 1026. Feedback to the infusiondevice 1010 on status or programming changes are displayed on an LCD1028 and/or audibly through a speaker 1030. In alternative embodiments,the keypad 1024 may be omitted and the LCD 1028 may be used as a touchscreen input device or the keypad 1024 may utilize more keys ordifferent key arrangements then those illustrated in the figures. Theprocessor 1018 is also coupled to a drive mechanism 1032 that isconnected to a fluid reservoir containing fluid that is expelled throughan outlet 1036 in the reservoir 1032 and housing 1020, and then into abody of a user through tubing and a set 1038. In further alternativeembodiments, the keypad 1024, LCD 1020, speaker 1024 may be omitted andthe infusion device is implanted in a body of the user, and allprogramming and data transfer is handled through the RF programmer 1012.

Several programming options will be available in the infusion device1010, and will include up to three customized basal profiles, acarbohydrate (or bolus) calculator and an alarm clock, as well as remoteand on-device programming. Additionally, a physician/educator will beable to configure the infusion device 1010 through a CommunicationsStation 1008 to provide or restrict access to certain programmingoptions. Particular embodiments of the infusion device 1010 will alsodownload stored information through the Communication-Station. Furtherdescription of a Communication Station of this general type is be foundin U.S. Pat. No. 5,376,070 to Purvis et al., entitled DATA TRANSFERSYSTEM FOR AN INFUSION PUMP, which is herein incorporated by reference.This information can be used alone or combined with information from aGlucose Meter and/or a Glucose Sensor to assist the user and/or thehealth care professional in making intelligent therapy decisions.Moreover, the information, programs and data may be downloaded to aremote or local PC, laptop, station, or the like, for analysis andreview by a MiniMed or a trained health care professional through thetransmitter/receiver 1026. The data may also be downloaded through aCommunication-Station 1008 to a remotely located computer 1006 such as aPC, lap top, or the like, over communication lines, by modem or wirelessconnection, as shown in FIG. 25.

The remote RF programmer 1012 (or remote commander) will enable the userto perform basic external infusion device 1010 programming steps withoutaccessing the keyboard 1024 on the external infusion device 1010 orlooking at the LCD (Liquid Crystal Display) 1028 screen. This willbenefit visually impaired users of the external infusion device 1010,since the remote RF programmer 1012 will give them ready access to themost commonly used operations of the external infusion device 1010, andwill obviate the need for visual feedback. Of particular importance tothe sight impaired will be the auditory feedback (and/or vibrationfeedback as discussed below) that the external infusion device 1010 willprovide. The instructions from the RF programmer 1012 will be confirmedby a series of audible beeps (or if requested by programming, vibration)from the external infusion device 1010. In alternative embodiments, theRF programmer 1012 may include a receiver and provide an audio (orvibration) indication that the commands have been received andacknowledged by the external infusion device 1010. In furtherembodiments, the keypad 1102 on the remote RF programmer 1012 will havethe letters defining the capability of the key encoded in Braille, andthe ridges that orient the user to the keypad 1102 will be quitepronounced to assist in guiding the user to the proper function key.Other embodiments may utilize keys that have different sizes or shapesto further enhance the ability for users to identify the correct buttonsto activate the various features and functions.

A remote RF programmer 1012 will provide convenience and discretion forthe user of the external infusion device 1010 by allowing concealment ofthe external infusion device 1010 under clothes, in pouches, or thelike. Preferably, the RF programmer 1012 is an optional accessory itemon the external infusion device 1010, and the external infusion device1010 will be fully functional without the use of the RF programmer 1012.However, in alternative embodiments, the keypad 1024 in the externalinfusion device 1010 may be omitted and all programming would be handledby a local or remote PC, laptop, Communication-Station, RF programmer orthe like. In preferred embodiments, the RF programmer 1012 will alsoprovide the user with the ability to perform the following functions:deliver a bolus, suspend/restart the external infusion device, and setand cancel a temporary basal rate. However, in alternative embodiments,the RF programmer may include still additional capabilities such as datatransfer (e.g., external infusion device history data or data from othermedical devices), updates to software and programming, or the like. Inpreferred embodiments, the data transfer capabilities between the RFprogrammer 1012 and the transmitter/receiver 1026 of the externalinfusion device 1010 are two-way. In alternative embodiments, the datatransfer from the RF programmer 1012 to the external infusion device1010 is one-way, such that the RF programmer 1012 does not receivetransmissions from the external infusion device 1010. In furtherembodiments, the RF programmer acts as a relay, or shuttle, for datatransmission between the external infusion device 1010 and a PC, laptop,Communication-station, or the like.

In addition, as shown in FIG. 26, a relay or repeater 1004 may be usedwith an external infusion device 1010 and an RF programmer 1012 toincrease the distance from which the RF programmer 1012 can be used withthe external infusion device 1010. For example, the relay could be usedto provide information to parents of children using the externalinfusion device 1010 and allow them to program the external infusiondevice 1010 from a distance with the RF programmer 1012. The informationcould be used when children are in another room during sleep or doingactivities in a location remote from the parents. In furtherembodiments, the relay 1004 can include the capability to sound analarm. In addition, the relay 1004 may be capable of providing externalinfusion device 1010 information to a remotely located individual via amodem connected to the relay 1004 for display on a monitor, pager or thelike. In a still further embodiment of the present invention, theexternal infusion device 1010 is capable of being programmed by multipleRF programmers 1012, as shown in FIG. 27. For instance, each RFprogrammer 1012 would learn (or be programmed with) the unique code(discussed below) of the external infusion device 1010. This would beuseful for users that desired to have multiple RF programmers 1012, suchas at home, office and/or school or needed a replacement for an RFprogrammer that was lost.

In preferred embodiments, the RF programmer 1012 is similar inappearance to the type of remote that is used to lock and unlock cardoors. It will have four (4) keys on a keypad 1102 on a housing 1104,which will be laid out in a square grid pattern, similar in appearanceand layout to the keypad 1024 on the infusion device 1010, as shown inFIGS. 22 and 23. In alternative embodiments, fewer keys may be used tosimplify the RF programmer, reduce manufacturing costs and/or to reducethe number of program capabilities available. Preferably, the RFprogrammer 1012 should include a ring 1106 that fits on a key ring tolessen the likelihood that it is lost. It should also have a “quickrelease” feature to allow the user to disconnect it from the key ring.

Preferred embodiments utilize RF frequencies; however, alternativeembodiments, may use optical, infrared (IR), ultrasonic frequencies,magnetic effects, or the like, to communicate with the external infusiondevice 1010.

Alternative embodiments of the RF programmer (controller or commander)1012′, as shown in FIG. 24, may have more complex keypad arrangements1152, and may include a display device 1150, such as an LCD, LED, plasmascreen, or the like, to assist in programming the external infusiondevice 1010. Further alternatives may include a microphone (not shown)and related circuitry to allow voice activated control of the externalinfusion device. In further alternative embodiments, the RF programmer1012′ may be formed in larger sizes, comparable to a TV controller or apocket calculator, and may include a display to facilitate morecomplicated or easier programming. Still further embodiments, mayinclude the ability to receive data and information from the externalinfusion device 1010 and/or a glucose monitoring device, and the abilityto relay the information to another medical device, external infusiondevice 1010, glucose monitor device, PC, laptop, Communication-Station,or the like. Data transmission may be to other devices or include thecapability to receive data or instructions. An RF activation capabilitymay be included in addition to the programming capability.

In preferred embodiments, the external infusion device 1010 includes areceiver to receive the commands from the RF programmer 1012. Normally,the receiver is in a standby mode (e.g., not receiving) and becomesactive for short periods every 2.5 seconds (approximately) to see ifthere is any RF activity from the RF programmer 1012. In alternativeembodiments, the receiver of the external infusion device 1010 may be oncontinuously or may become active more often or less often, with theselection being dependent on power capacity, expected frequency of useof the RF programmer 1012, or the like. Generally, the receiver of theexternal infusion device 1010 requires that the RF programmer send anactivating message for a period lasting about 5 seconds for the RFprogrammer to be recognized by the receiver. In alternative embodiments,longer or shorter periods of time for sending the activating message maybe used.

Once the receiver recognizes that there is a valid RF programmer 1012sending a message to the external infusion device 1010 (i.e., with thisdevice 1010′s unique code), the receiver will remain in an active modeuntil a complete sequence of commands has been received, or until thereceiver times out due to a lack of RF communications from the RFprogrammer 1012. Preferably, upon recognition of a valid RF programmer1012 trying to communicate with the receiver, the external infusiondevice 1010 will activate its audio beeper (or its vibrator or the like)to let the user know that the external infusion device 1010 has beenactivated by the RF programmer 1012. Typically, the receiver of theinfusion device 1010 expects to receive a message with a valid preambleand message type, a recognized unique code, a valid function code (e.g.,activate, bolus, suspend, or the like), an appropriate message countused by the receiver for reduction of RF interference problems, and avalid CRC on the transmitted message to ensure message integrity.Alternative embodiments, may include different message contents orcomponents.

In operation, as discussed above, the RF programmer 1012 may be used toprogram several capabilities, such as an audio (or vibration) bolus, asuspension of external infusion device operation, a temporary basalrate, an extended bolus (such as square wave, ramp, triangular or thelike) or dual wave bolus. In addition, the user may program a profiledbolus that uniquely matches the needs of the individual user (forinstance it may contain square, ramp, pulse or curved portions that makeup the profile to be delivered over a period of time). It should benoted that the capabilities may also be directly programmed on theexternal infusion device 1010 using the same sequence on the keypad ofthe external infusion device 1010.

The RF programmer 1012′, since it includes a display 1150 may use thesame programming protocol and key sequences as those used to program theexternal infusion device 1010 using the keypad 1024 and LCD 1028 on theexternal infusion device 1010. Alternatively, the RF programmer 1012′may use more sophisticated programming techniques, such as single keyprogramming, if the display 1150 includes the capability to use touchscreen techniques, or may use additional keys in the keypad 1152 thatare specifically identified with particular programming features on theexternal infusion device 1010.

The Bolus estimator 1014 (or carbohydrate estimator that estimates abolus based on carbohydrate consumption (CHO)) assists the user withcarbohydrate counting and in determining precise dosing adjustments toaccount for meals. Carbohydrates are the primary, but not the only,factor affecting blood glucose levels. Generally, it is sufficient toaccount just for the carbohydrates. It also encourages the user to entercurrent blood glucose values before using this feature, which will alsobe viewed quite favorably by the health care professional, since itincreases compliance with the medical regimen and improves control. Inalternative embodiments, the bolus estimator 1014 in the externalinfusion device 1010 can be connected or coupled to a glucose monitor byway of the RF programmer 1012 (or other data transfer) to provide directinput to the bolus estimator 1014. In still further embodiments, theexternal infusion device 1010 may utilize a more complicated keypadand/or RF programmer 1012, and a code is assigned for each food. Thenthe code for each food to be consumed is entered into the externalinfusion device 1010. An example of Bolus Estimators can be found inU.S. Patent Application Ser. No. 60/096,994 filed Aug. 18, 1998 and isentitled “INFUSION DEVICE WITH REMOTE PROGRAMMING, CARBOHYDRATECALCULATOR AND/OR VIBRATION ALARM CAPABILITIES,” or U.S. patentapplication Ser. No. 09/334,858 filed Jun. 17, 1999 and is entitled“EXTERNAL INFUSION DEVICE WITH REMOTE PROGRAMMING, BOLUS ESTIMATORAND/OR VIBRATION ALARM CAPABILITIES,” both of which are hereinincorporated by reference.

Further embodiments of the present invention include a vibration alarm1016 that provides a noticeable vibration in addition to or in lieu ofan audible alarm. The resulting tactile sensation of the vibration makethe alarms more noticeable during sleep, when not thinking clearly dueto various conditions, or the like, to improve the likelihood that theuser will respond to an alarm. Thus, a vibration alarm 1016 can improvesafety and control. In addition, the vibration alarm 1016 may be lesspublicly noticeable, and thus more useable in quiet settings, such aslibraries, lectures, shows, or the like, or in loud settings where thealarm might go unnoticed, such as parties, concerts, or the like. Infurther embodiments, the RF programmer 1012 may include a vibrationalarm (not shown) that can deliver a vibration alarm to the user inaddition to, or instead of, the vibration alarm 1016 from the externalinfusion device 1010. Alternatively, the RF programmer 1012 may providea vibration alarm and the external infusion device 1010 may provide anaudible or vice versa. In preferred embodiments, all alarms willgradually escalate in frequency or volume so that the user can terminatethem as soon as they are noticed. In alternative embodiments, the alarmsmay change tones or intermittently stop to draw attention to the alarmcondition. In further alternatives, the infusion device 1010 may use thetransmitter/receiver 1026 to transmit the alarm to a remotely locateddevice, such as a communication-station, modem or the like to summonhelp.

In addition, as shown in FIG. 29, a relay 2004 may be capable ofproviding sensor set 2150 and telemetered characteristic monitortransmitter 2100 data to a remotely located individual via a modemconnected to the relay 2004 for display on a monitor, pager or the like.The data may also be downloaded through a Communication-Station 2008 toa remotely located computer 2006 such as a PC, lap top, or the like,over communication lines, by modem or wireless connection, as shown inFIG. 29. Also, some embodiments may omit the Communication Station 2008and uses a direct modem or wireless connection to the computer 2006. Infurther embodiments, the telemetered characteristic monitor transmitter2100 transmits to an RF programmer, which acts as a relay, or shuttle,for data transmission between the sensor set 2150 and a PC, laptop,Communication-station, station, or the like. The telemeteredcharacteristic monitor transmitter 2100 and characteristic monitor 2200may also be combined with other medical devices to combine other patientdata through a common data network and telemetry system.

As shown in FIGS. 30-33, a characteristic monitor 2200 may include adisplay 2208 that is used to display the results of the measurementreceived from the sensor in the sensor set 2150 via the telemeteredcharacteristic monitor transmitter 2100. The results and informationdisplayed includes, but is not limited to, trending information of thecharacteristic (e.g., rate of change of glucose), graphs of historicaldata, average characteristic levels (e.g., glucose), or the like.Alternative embodiments include the ability to scroll through the data.The display 2208 may also be used with a keypad 2202 on thecharacteristic monitor to program or update data in the characteristicmonitor 2200. It is noted that the typical user can be expected to havesomewhat diminished visual and tactile abilities due to complicationsfrom diabetes or other conditions. Thus, the display 2208 and keypad2202 should be configured and adapted to the needs of a user withdiminished visual and tactile abilities. In alternative embodiments, thevalue can be conveyed to the user by audio signals, such as beeps,speech or the like. Still further embodiments may use a touch screeninstead of (or in some cases addition to) keypad 2202 to facilitatewater proofing and to ease changes in the characteristic monitor 2200hardware to accommodate improvements or upgrades.

In further embodiments of the present invention, the characteristicmonitor 2200 may be replaced by a different device. For example, in oneembodiment, the telemetered characteristic monitor transmitter 2100communicates with an RF programmer (see FIGS. 1-29) that is also used toprogram and obtain data from an infusion pump 1010 or the like. The RFprogrammer may also be used to update and program the transmitter 2100,if the transmitter 2100 includes a receiver for remote programming,calibration or data receipt. The RF programmer can be used to store dataobtained from the sensor set 2150 and then provide it to either aninfusion pump 1010, characteristic monitor, computer or the like foranalysis. In further embodiments, the transmitter 2100 may transmit thedata to a medication delivery device, such as an infusion pump or thelike, as part of a closed loop system. This would allow the medicationdelivery device to compare sensor results with medication delivery dataand either sound alarms when appropriate or suggest corrections to themedication delivery regimen. In preferred embodiments, the transmitter2100 would include a transmitter to receive updates or requests foradditional sensor data. An example of one type of RF programmer can befound in U.S. Patent Application Ser. No. 60/096,994 filed Aug. 18, 1998and is entitled “INFUSION DEVICE WITH REMOTE PROGRAMMING, CARBOHYDRATECALCULATOR AND/OR VIBRATION ALARM CAPABILITIES,” or U.S. patentapplication Ser. No. 09/334,858 filed Jun. 17, 1999 and is entitled“EXTERNAL INFUSION DEVICE WITH REMOTE PROGRAMMING, BOLUS ESTIMATORAND/OR VIBRATION ALARM CAPABILITIES,” both of which are hereinincorporated by reference.

In further embodiments, the telemetered characteristic monitortransmitter 2100 can include a modem, or the like, to transfer data toand from a healthcare professional. Further embodiments, can receiveupdated programming or instructions via a modem connection.

As shown in FIGS. 30-33, in preferred embodiments, the microprocessor2216 is coupled to a data input and output (I/O) port 2210, and the usercan download the stored information to an external computer (see FIGS.1, 10 and 29), or the like, through the data I/O port 2210 forevaluation, analysis, calibration, or the like. Preferably, the data I/Oport 2210 is capable of transferring data in both directions so thatupdated program instructions or reminder alarms can be set by the useror doctor. In preferred embodiments, the I/O port 2210 uses infrared(IR) technology, such as that shown and described in U.S. Pat. No.5,376,070 entitled “Data Transfer System for an Infusion Pump”, or thelike, which is herein incorporated by reference. However, in alternativeembodiments, the I/O port 2210 may use other data transfer technologiessuch as cables, fiber optics, RF, or the like. In still otherembodiments, the data I/O port 2210 may include multiple ports tosupport multiple communication protocols or methods, or may include auniversal port capable of transmitting data in several different modes.In preferred embodiments, the stored data may be downloaded to (or newprogram instructions and data uploaded from) a computer, communicationstation, or the like. In alternative embodiments, the stored data may bedownloaded to (or new program instructions and data uploaded from) aninfusion pump, or the like. In preferred embodiments, the characteristicmonitor 2200 is the approximate size of a conventional glucose meter orsmaller. However, in alternative embodiments, the characteristic monitor2200 may be formed in larger sizes, comparable to a TV controller or apocket calculator, and may include a larger display 2208 to facilitatemore complicated or easier programming.

The keypad 2202 provides the user with the capability to storeadditional information, set the date and the time, or set alarms toindicate when to take the next test with the characteristic meter 2300.The keypad 2202 is used in conjunction with the display 2208 to accessthe various modes, alarms, features, or the like, by utilizing methodstypically employed to set the parameters on a conventional glucosemeter, an infusion pump, or the like. The keypad 2202 may also be usedto manipulate the stored data in the characteristic monitor 2200 anddisplay the data on the on-board display 2208.

The programs for controlling the sensor monitor 2212 of thecharacteristic monitor 2200 are also stored in the ROM 2204, and sensordata signal values received by the sensor interface 2214 from the sensorset 2150 are processed by the sensor monitor 2212 and the microprocessor2216, and then the results are stored in the RAM 2206. The sensormonitor 2212 and the sensor interface 2214 can be activated by a wiredconnection to a sensor set 2150 that draws power from the characteristicmonitor, by receipt of a signal from the telemetered characteristicmonitor transmitter 2100, or by the keypad 2202. Preferred embodimentsuse a characteristic monitor 2200 (in which the system includes aPotentiostat such as sensor monitor 2212) to receive the sensor signalsfrom a telemetered characteristic monitor transmitter 2100, as shown inU.S. Patent Application Ser. No. 60/103,812 entitled “TelemeteredCharacteristic Monitor System and Method of Using the Same”, which isherein incorporated by reference. In alternative embodiments, the sensorsignals may be received on a more infrequent (or periodic) basis from aHolter-type monitor system, as shown in U.S. patent application Ser. No.09/246,661 entitled “An Analyte Sensor and Holter-type Monitor Systemand Method of Using the Same”, which is herein incorporated byreference.

As shown in FIGS. 30-33, the characteristic monitor 2200 includes adisplay 2208 that is used to display the results of the measurementreceived from the sensor in the sensor set 2150 via a cable andconnector 2180 attached to the telemetered characteristic monitortransmitter 2100, or the like. In preferred embodiments, the displaydevice 2208 is an active matrix LCD. However, alternative embodimentsmay use other display devices, such as simplified LCD, LED, fluorescentelement, plasma screen, or the like. The results and informationdisplayed includes, but is not limited to, trending information of thecharacteristic (e.g., rate of change of glucose), graphs of historicaldata, average characteristic levels (e.g., glucose), or the like.Alternative embodiments include the ability to scroll through the data.The display 2208 may also be used with the keypad 2202 on thecharacteristic monitor 2200 to program or update data in thecharacteristic monitor 2200. In addition, the calibrated data usingresults from the characteristic meter 2300 can be displayed to provide auser with updated trend and glucose level data. This may also be used toupdate and show differences between the newly calibrated (or additionalcalibration) data and the data as it was prior to the new calibration(or additional calibration).

In other embodiments, if multiple characteristic sensors are used, theindividual data for each characteristic sensor may be stored anddisplayed to show a comparison and an average between the twocharacteristic sensors.

It is noted that a typical user can have somewhat diminished visual andtactile abilities due to complications from diabetes or otherconditions. Thus, the display 2208 and keypad 2202 are preferablyconfigured and adapted to the needs of a user with diminished visual andtactile abilities. In alternative embodiments, the data, analyte levelvalue, confirmation of information, or the like can be conveyed to theuser by audio signals, such as beeps, speech or the like, or vibrations.Still further embodiments may use a touch screen instead of (or in somecases addition to) the keypad 2202 to facilitate water proofing and tominimize changes in the characteristic monitor 2200 hardware toaccommodate improvements or upgrades. Additional embodiments of thepresent invention may include a vibrator alarm (or optional indicatorsuch as an L.E.D.) in either, or both, the telemetered characteristicmonitor transmitter 2100 and the characteristic monitor 2200 to providea tactile (vibration) alarm to the user, such as sensor set 2150malfunction, improper connection, low battery, missed message, bad data,transmitter interference, or the like. The use of a vibration alarmprovides additional reminders to an audio alarm, which could beimportant to someone suffering an acute reaction, or where it isdesireable to have non-audio alarms to preserve and conceal the presenceof the characteristic monitor system 2010.

As shown in FIG. 33, further embodiments of the characteristic monitor2200 may be used with a telemetered characteristic monitor transmitter2100 coupled to a sensor set 2150 and an infusion pump 1010 connected toan infusion set 1038. In this embodiment, the characteristic monitor2200 is also used to program and obtain data from the infusion pump1010, or the like. This further reduces the amount of equipment, theuser must have, since the characteristic monitor 2200 already includes acharacteristic meter 2300 that will be required for calibration of thedata from the telemetered characteristic monitor transmitter 2100. Thus,the characteristic monitor 2200 can coordinate the sensor data and meterdata with the data from the infusion pump 1010, or update the deliveryparameters of the infusion pump 1010. The characteristic monitor 2200may also be used to update and program the telemetered characteristicmonitor transmitter 2100, if the transmitter 2100 includes a receiverfor remote programming, calibration or data receipt. Thus, the user mayneed only a single device—the characteristic monitor 2200 that willreceive data from a sensor set 2150, perform discrete tests of ananalyte with the characteristic meter 2300, program and control aninfusion pump 1010, and operate to download data or upload programminginstructions to a computer, communication station, or the like.

As discussed, the characteristic monitor 2200 can also be used to storedata obtained from the sensor set 2150 and then provide it to either aninfusion pump 1010, computer or the like for analysis. In furtherembodiments, the characteristic monitor 2200 can include a modem, or thelike, to transfer data to and from a healthcare professional. Furtherembodiments, can receive updated programming or instructions via a modemconnection. In addition, a relay or repeater 2004 may be used with atelemetered characteristic monitor transmitter 2100 and a characteristicmonitor 2200 to increase the distance that the telemeteredcharacteristic monitor transmitter 2100 can be used with thecharacteristic monitor 2200, as shown in FIG. 28. For example, the relay2004 could be used to provide information to parents of children usingthe telemetered characteristic monitor transmitter 2100 and the sensorset 2150 from a distance. The information could be used when childrenare in another room during sleep or doing activities in a locationremote from the parents. In further embodiments, the relay 2004 caninclude the capability to sound an alarm. In addition, the relay 2004may be capable of providing data from sensor set 2150 and telemeteredcharacteristic monitor transmitter 2100 to a remotely located individualvia a modem connected to the relay 2004 for display on a monitor, pageror the like. In alternative embodiments, the data from thecharacteristic monitor 2200 and sensor set 2150 may also be downloadedthrough a communication station 2008 (or alternatively, through acharacteristic monitor 2200, other data transfer device, or the like) toa remotely located computer 2006 such as a PC, lap top, or the like,over communication lines, by modem or wireless connection, as shown inFIG. 29. Also, some embodiments may omit the communication station 2008and use a direct modem or wireless connection to the computer 2006. Infurther alternatives, either the characteristic monitor 2200 or thetelemetered characteristic monitor transmitter 2100 may transmit analarm to a remotely located device, such as a communication-station,modem or the like to summon help. In addition, further embodiments ofthe characteristic monitor 2200 may include the capability forsimultaneous monitoring of multiple sensors. Data transmission may be toother devices or include the capability to receive data or instructionsfrom other medical devices. Preferred embodiments, as shown in FIGS. 31and 33, use wireless RF frequencies; however, alternative embodimentsmay utilize IR, optical, ultrasonic, audible frequencies or the like.Further embodiments may also use a wired connection, as shown in FIG.32.

Preferably, the characteristic monitor system 2010 combines thecharacteristic monitor 2200 and character meter 2300 into a singledevice, but avoids an actual wired connection to the sensor set 2150 byusing a telemetered characteristic monitor transmitter 2100. Byseparating the characteristic monitor system 2010 electronics into twoseparate devices; a telemetered characteristic monitor transmitter 2100(which attaches to the sensor set 2150) and a characteristic monitor2200, several advantages are realized. For instance, the user can moreeasily conceal the presence of the characteristic monitor system 2010,since a wire will not be visible (or cumbersome), with clothing. In alsomakes it is easier to protect the characteristic monitor 2200, which canbe removed from the user's body during showers, exercise, sleep or thelike. In addition, the use of multiple components (e.g., transmitter2100 and characteristic monitor 2200 with a characteristic meter)facilitates upgrades or replacements, since one module or the other canbe modified or replaced without requiring complete replacement of thecharacteristic monitor system 2010. Further, the use of multiplecomponents can improve the economics of manufacturing, since somecomponents may require replacement on a more frequent basis, sizingrequirements may be different for each module, there may be differentassembly environment requirements, and modifications can be made withoutaffecting the other components.

FIG. 1 is a perspective view of a system 1 using a handheld dataassistant (PDA) 10 and computer 12 in accordance with an embodiment ofthe present invention. Preferred embodiments, use a PDA 10 such as theVisor 1003E by Handspring. However, alternative embodiments, may usestandard or customized personal data assistants such as, but not limitedto, the Palm Pilot, Palm III, Palm V and/or Palm VII by Palm Computing adivision of 3 COM, the PCS NP 1000 by Sprint, the pdQ 1900 by Qualcomm,the AutoPC by Clarion, Newton by Apple, the Cassiopeia by Casio,Blackberry by Research In Motion Limited, or the like. In preferredembodiments, the computer 12 includes a computer processing unit 14, amonitor 16, a key board 18 and a mouse 20. The computer 12 also includesa PDA cradle 22 connected to the computer 12 by a cable 24 to providetwo-way data communication between the PDA 10 and the computer 12. Inalternative embodiments, the PDA cradle 22 may connect to the computerusing a wireless connection. In further alternative embodiments, the PDAcradle 22 may be omitted and the PDA 10 includes a receiver andtransmitter and/or a jack to provide the two-way communication betweenthe PDA 10 and the computer 12. In further alternative embodiments, thecomputer 12 may be replaced with a different processing device, such asa data processor, a laptop computer, a modem or other connection to anetwork computer server, an internet connection, or the like.

FIGS. 2 and 3 are views of a PDA 10 with a medical device module 200 inaccordance with an embodiment of the present invention. The PDA 10includes a display 102 mounted in a case 104. The case includes aplurality of physical keys 106 and 108 to activate and control variousfeatures on the PDA 10. The display 102 of the PDA 10 is a touch screenLCD that allows the display of various icons 110 representative ofdifferent programs available on the PDA 10. The icons 110 on the display102 may be activated by finger pressure or the touch of a stylus 112.The display 102 may also be used to show graphs, tabular data,animation, or the like. The display 102 also includes a region with hardicons 114 that represent regular program activating features and awriting area 116 for entering data using the stylus 112. Preferredembodiments of the PDA 10 are adapted for use of the Palm computingsoftware and standards developed by 3 Com. However, alternativeembodiments may use computing software and standards produced by othercompanies.

As shown in FIG. 3, the PDA 10 has a slot 120 formed in the back 124 ofthe case 104 of the PDA 10 for receiving the medical device module 200.The slot 120 includes connector contacts 122 that mate withcorresponding contacts 222 on the medical device module 200. Thus, thePDA 10 provides a standard user interfaces, including standard PDAfeatures and programmability, that the user knows and understands. Amedical device manufacturer primarily only needs to design, build andqualify a medical device module that interfaces with a standard PDA 10interface and uses the existing hardware of the PDA 10 to interact withthe user. Therefore, a medical device manufacturer focuses primarily ona medical device module that can be interchanged by the user to providethe user with a desired capability or function on a known and/orfamiliar device, the PDA 10. Further embodiments (not shown) may usemultiple medical device modules or a medical device module that includesmore than one medical device sub-module.

FIG. 4 illustrates a perspective view of a PDA 10, in accordance with apreferred embodiment of the present invention. The PDA 10 includes asubcutaneous sensor set 150 (i.e., a sensor portion is implanted in, forexample, dermal subdermal, subcutaneous tissues, or the like), atelemetered characteristic monitor transmitter 100 connected to thesensor set 150 through a sensor cable/connector 180, and a medicaldevice module 200 that includes a characteristic monitor 200′ and acharacteristic meter 300. The subcutaneous sensor set 150 utilizes anelectrode-type sensor, as described in more detail in U.S. Pat. No.5,391,250, entitled “Method Of Fabricating Thin Film Sensors”, U.S. Pat.No. 5,482,473, entitled “Flex Circuit Connector”, U.S. Pat. No.5,390,671, entitled “Transcutaneous Sensor Insertion Set”, U.S. Pat. No.5,568,806, entitled “Transcutaneous Sensor Insertion Set”, U.S. Pat. No.5,586,553, entitled “Transcutaneous Sensor Insertion Set”, U.S. Pat. No.5,779,655, entitled “Transducer Introducer Assembly” and co-pending U.S.Pat. No. 5,954,643, entitled “Insertion Set for a TranscutaneousSensor,” all of which are herein incorporated by reference. However, inalternative embodiments, the sensor may use other types of sensors, suchas chemical based, optical based, or the like. In further alternativeembodiments, the sensors may be of a type that is used on the externalsurface of the skin or placed just below the skin layer of the user.Preferred embodiments of a surface mounted sensor would utilizeinterstitial fluid harvested from underneath the skin.

The telemetered characteristic monitor transmitter 100 generallyincludes the capability to transmit data. However, in alternativeembodiments, the telemetered characteristic monitor transmitter 100 mayinclude a receiver, or the like, to facilitate two-way communication ofdata reading between the sensor set 150 and the characteristic monitor200′ of the medical device module 200. The characteristic monitor 200′in the medical device module 200 utilizes the transmitted data todetermine the characteristic reading. Although a telemetered approachthat utilizes RF is preferred, other wireless techniques, such asoptical, IR, ultrasonic, or the like may be used. In addition, wiredconnections may be utilized instead of a telemetered transmission ofdata from the sensor 150 to the medical device module 200 (see FIG. 18below).

The characteristic meter 300 utilizes test strips 350, or the like, witha sample obtained from the body of the patient to determine acharacteristic (or analyte level) in a user at a discrete point in time.The discrete measurement from the characteristic meter 300 is stored ina memory of the medical device module 200 and may be used to calibratethe characteristic monitor 200′ in the medical device module 200 againstthe test results from the characteristic meter 300, either in real timeor using a post calibration in either the characteristic monitor 200′ inthe medical device module 200 or during later analysis and review oncethe test results have been downloaded to a separate computer,communication station, or the like. Possible characteristic meters 300that may be used are produced by Roche Diagnostics, Bayer Corporation,Abbott Medisense, Johnson & Johnson, Mercury Diagnostics, Chronimed, orthe like.

FIG. 5 illustrates a simplified flow block diagram of the medical devicemodule 200 shown in FIGS. 4 and 6. As shown in FIG. 5, the medicaldevice module 200 includes the characteristic meter 300 and also thecharacteristic monitor 200′ that interfaces with a sensor set 150. Themedical device module 200 includes a keypad interface 202, a ROM 204, aRAM 206, a display interface 208, a data Input and Output (I/O) port 210that uses the contacts 222 on the medical device module 200 to connectwith the contacts 122 on the PDA 10, a sensor monitor 212, a sensorinterface 214, a microprocessor 216, and a battery and/or power supply218. An overlapping subset of these elements is used to process the datafrom the sensor 150 and is collectively shown as the characteristicmonitor 200′. The characteristic meter 300, included in the medicaldevice module 200, includes a characteristic test meter 302 and a testinterface 304.

The microprocessor 216 of the medical device module 200 is activated inseveral different ways. The keypad interface 202 is coupled directly tothe microprocessor 216 and is useable to activate the microprocessor 216upon activation of the keys 106 and 108 and/or display 102 of the PDA10. The microprocessor 216 is then prepared to store relevantinformation concerning the sensor data, meter readings, event data, orthe like. For instance, the microprocessor 216 will store, the time, thedate and the analyte level from a test strip 350 or may be used torecord an independent event by the user. In addition, the keypadinterface 202, unpin interfacing with the PDA 10, may be used toactivate and control the microprocessor 216 to perform analysis,calibration, control the display interface 208 and display 102, downloadstored data and results, upload program instructions, or the like. Themicroprocessor 216 may also be activated by receiving a specified signalfrom the sensor interface 214 indicating connection or receipt of datafrom a sensor 150 and/or by insertion of a test strip 350 into the testinterface 304 of the included characteristic meter 300. Once activated,the microprocessor 216 stores data, analyzes signal values, testsresults for accuracy, calibrates, downloads data, presents data forreview and analysis, provides instructions, warnings and alarms, or thelike.

The microprocessor 216 is coupled to a ROM 204 and a RAM 206. Inpreferred embodiments, the ROM 204 is an EPROM and the RAM 206 is astatic RAM; however, other comparable memory storage components such asdynamic RAM, non-static RAM, rewritable ROMs, flash memory, or the like,may be used. Generally, the ROM 204 stores the programs used by themicroprocessor 216 to determine various parameters, such as the amountof an analyte corresponding to a received signal value in the sensormonitor 212 signal value, calibration techniques for adjusting thesensor signals from the sensor 150, characteristic meter 300 operationand correspondence of test results with the sensor signal values, thedate and the time, and how to report information to the user. The RAM206 is used by the microprocessor 216 to store information about thesensor signal values and test strip 350 test results for later recall bythe user or the doctor. For example, a user or doctor can transcribe thestored information at a later time to determine compliance with themedical regimen or a comparison of analyte value levels to medicationadministration. This is accomplished by downloading the information tothe display 102 through the display interface 208 and then transcribingall of the stored records at one time as they appear on the display 208.In addition, the RAM 206 may also store updated program instructionsand/or patient specific information.

In preferred embodiments, the microprocessor 216 is coupled to a datainput and output (I/O) port 210 that uses the contacts 222 on themedical device module 200 to connect with the contacts 122 on the PDA10, and the user can download the stored information to an externalcomputer (see FIG. 1), or the like, through the data I/O port 210 forevaluation, analysis, calibration, or the like. Preferably, the data I/Oport 210 is capable of transferring data in both directions so thatupdated program instructions or reminder alarms can be set by the useror doctor. In preferred embodiments, the I/O port 210 uses the infrared(IR) technology of the PDA 10 or may include its own IR transceiverssimilar to those shown and described in U.S. Pat. No. 5,376,070 entitled“Data Transfer System for an Infusion Pump”, or the like, which isherein incorporated by reference. However, in alternative embodiments,the I/O port 210 may use other data transfer technologies such ascables, fiber optics, RF, or the like. In still other embodiments, thedata I/O port 210 may include multiple ports to support multiplecommunication protocols or methods, or may include a universal portcapable of transmitting data in several different modes. In preferredembodiments, the stored data may be downloaded to (or new programinstructions and data uploaded from) a computer, communication station,or the like. In alternative embodiments, the stored data may bedownloaded to (or new program instructions and data uploaded from) aninfusion pump, or the like.

The keypad interface 202 provides the user with the capability to setparameters in the medical device module using the keys 106 and 108and/or display 102 of the PDA 10. Such capabilities include, but are notlimited to, storing additional information, setting the date and thetime, or setting alarms to indicate when to take the next test with thecharacteristic meter 300. The keypad interface 202 is used inconjunction with the display interface 208 to access the various modes,alarms, features, or the like, by utilizing methods typically employedto set the parameters on a conventional glucose meter, an infusion pump,or the like. Except this is all done through the use of a standard PDAinterface.

The medical device module 200 also includes a self contained battery andpower supply 218. Preferably, the medical device module 200 usesbatteries (not shown) to provide power to the medical device module 200.For example, a plurality of silver oxide batteries, such as two orthree, may be used. However, it is understood that different batterychemistries may be used, such as lithium, alkaline or the like, anddifferent numbers of batteries can be used. In preferred embodiments,the batteries have a life in the range of 1 month to 1 year, and providea low battery warning alarm. Alternative embodiments may provide longeror shorter battery lifetimes, or include a power port to permitrecharging of rechargeable batteries in the medical device module 200.Further alternative embodiments may use the power supply (not shown)that is already included in the PDA 10 or recharge its own batteriesthrough the power supplied by the cradle 22.

The ROM 204 of the medical device module 200 also stores additionalprograms to operate and control the characteristic meter 300. Moreover,the RAM 206 of the medical device module 200 can stores results obtainedfrom the characteristic meter 300. As shown in FIG. 5, a test strip 350for holding an analyte sample is inserted into the test interface 302.This activates the characteristic test meter 304 and the microprocessor216. The characteristic test meter 304 analyzes the characteristics andsends the analysis results to the microprocessor 216, which displays theresults on the display 102 and stores the results in the RAM 206 forlater review.

The programs for controlling the sensor monitor 212 of thecharacteristic monitor 200′ are also stored in the ROM 204, and sensordata signal values received by the sensor interface 214 from the sensorset 150 are processed by the sensor monitor 212 and the microprocessor216, and then the results are stored in the RAM 206. The sensor monitor212 and the sensor interface 214 can be activated by a wired connectionto a sensor set 150 that draws power from the characteristic monitor, byreceipt of a signal from the telemetered characteristic monitortransmitter 100, or by the keys 106 and 108 and/or display 102 throughthe keypad interface 202. Preferred embodiments use a characteristicmonitor 200′ (in which the system includes a Potentiostat such as sensormonitor 212) to receive the sensor signals from a telemeteredcharacteristic monitor transmitter 100, as shown in U.S. patentapplication Ser. No. 09/377,472 entitled “Telemetered CharacteristicMonitor System and Method of Using the Same”, which is hereinincorporated by reference. In alternative embodiments, the sensorsignals may be received on a more infrequent (or periodic) basis from aHolter-type monitor system, as shown in U.S. patent application Ser. No.09/246,661 entitled “An Analyte Sensor and Holter-type Monitor Systemand Method of Using the Same”, which is herein incorporated byreference.

Preferred embodiments store the raw received sensor signals values fromthe sensor monitor 212 and the test results from the characteristic testmeter 304 of the characteristic meter in the RAM 206. However,alternative embodiments may also store calibrated and adjusted resultsin the RAM 206 for downloading, later analysis and review. Furtherembodiments may only store adjusted results.

Once activated, the sensor interface 214 continuously, intermittently ornear continuously receives signals from the sensor set 150 that arerepresentative of an analyte level being monitored in a user. Inpreferred embodiments, the sensor monitor 212 is used in conjunctionwith the microprocessor 216 to store, smooth the data and determine acorresponding analyte level from the signals received from the sensorinterface 214. The corresponding value may be shown on the display 208.The characteristic monitor 200′ of the medical device module 200 mayalso perform calibration of the sensor signal values using valuesprovided by the characteristic meter 300. The calibration may beperformed on a real-time basis and/or backwards recalibrated (e.g.,retrospectively). In further embodiments, the microprocessor 216monitors the sensor signals from the sensor monitor 212 to determinewhen the characteristic meter 300 should be used to perform tests to beused for calibration of the sensor data signals. For instance, themicroprocessor 216 could indicate that the calibration test should bedelayed if the sensor data signals from the sensor monitor 212 arechanging too rapidly and suggest a calibration reading when the sensordata readings are relatively stable. Also, the characteristic monitor200′ of the medical device module 200 may prompt the user to performcalibration at periodic preset intervals. Alternatively, thecharacteristic monitor 200′ of the medical device module 200 may promptthe user to perform the calibration based upon event-triggeredintervals, that are either user input, such as meals, exercise, or thelike, or that are trend input, such as large excursions in glucoselevels, faulty or interrupted data readings, or the like.

As shown in FIGS. 1-4, the PDA 10 includes a display 102 that is used todisplay the results of the measurement received from the sensor in thesensor set 150 via a cable and connector 180 attached to the telemeteredcharacteristic monitor transmitter 100, or the like. The results andinformation displayed includes, but is not limited to, trendinginformation of the characteristic (e.g., rate of change of glucose),graphs of historical data, average characteristic levels (e.g.,glucose), or the like. Alternative embodiments include the ability toscroll through the data. The display 102 may also be used with the key106 and 108 on the PDA 10 to program or update data in the medicaldevice module 200. In addition, the calibrated data using results fromthe characteristic meter 300 can be displayed to provide a user withupdated trend and glucose level data. This may also be used to updateand show differences between the newly calibrated (or additionalcalibration) data and the data as it was prior to the new calibration(or additional calibration).

In other embodiments, if multiple characteristic sensors are used, theindividual data for each characteristic sensor may be stored anddisplayed to show a comparison and an average between the twocharacteristic sensors.

It is noted that a typical user can have somewhat diminished visual andtactile abilities due to complications from diabetes or otherconditions. Thus, the display 102 and/or keys 106 and 108 are preferablyconfigured and adapted to the needs of a user with diminished visual andtactile abilities. In alternative embodiments, the data, analyte levelvalue, confirmation of information, or the like can be conveyed to theuser by audio signals, such as beeps, speech or the like, or vibrations.Further alternatives may include a microphone (not shown) and relatedcircuitry to allow voice activated control of the infusion device.

Additional embodiments of the present invention may include a vibratoralarm (or optional indicator such as an L.E.D.) in either, or both, thetelemetered characteristic monitor transmitter 100 and the medicaldevice module 200 to provide a tactile (vibration) alarm to the user,such as sensor set 150 malfunction, improper connection, low battery,missed message, bad data, transmitter interference, or the like. The useof a vibration alarm provides additional reminders to an audio alarm,which could be important to someone suffering an acute reaction, orwhere it is desirable to have non-audio alarms to preserve and concealthe presence of the characteristic monitor system 10.

FIGS. 7 and 8 show a second embodiment of the medical device module 200may be used with a telemetered characteristic monitor transmitter 100coupled to a sensor set 150 and an infusion pump 400 connected to aninfusion set 450. In this embodiment, the medical device module 200 isalso used to program and obtain data from the infusion pump 400, or thelike. This further reduces the amount of equipment, the user must have,since the medical device module 200 already includes a characteristicmonitor 200′ and a characteristic meter 300 that will be required forcalibration of the data from the telemetered characteristic monitortransmitter 100. Thus, the medical device module 200 can coordinate thesensor data and meter data with the data from the infusion pump 400, orupdate the delivery parameters of the infusion pump 400. The medicaldevice module 200 may also be used to update and program the telemeteredcharacteristic monitor transmitter 100, if the transmitter 100 includesa receiver for remote programming, calibration or data receipt. Thus,the user may need only a single device—the medical device module 200 inthe PDA 10 that will receive data from a sensor set 150, performdiscrete tests of an analyte with the characteristic meter 300, programand control an infusion pump 400, and operate to download data or uploadprogramming instructions to a computer, communication station, or thelike.

As discussed, the medical device module 200 can also be used to storedata obtained from the sensor set 150 and then provide it to either aninfusion pump 400, computer or the like for analysis. In furtherembodiments, the medical device module 200 can include a modem, or thelike, to transfer data to and from a healthcare professional. Furtherembodiments, can receive updated programming or instructions via a modemconnection. In addition, a relay or repeater 4 may be used with atelemetered characteristic monitor transmitter 100 and a medical devicemodule 200 to increase the distance that the telemetered characteristicmonitor transmitter 100 can be used with the medical device module 200,as shown in the third embodiment of FIG. 9. For example, the relay 4could be used to provide information to parents of children using thetelemetered characteristic monitor transmitter 100 and the sensor set150 from a distance. The information could be used when children are inanother room during sleep or doing activities in a location remote fromthe parents. In further embodiments, the relay 4 can include thecapability to sound an alarm. In addition, the relay 4 may be capable ofproviding data from sensor set 150 and telemetered characteristicmonitor transmitter 100 to a remotely located individual via a modemconnected to the relay 4 for display on a monitor, pager or the like. Inalternative embodiments, the data from the medical device module 200 andsensor set 150 may also be downloaded through a communication station 8(or alternatively, through a medical device module 200, other datatransfer device, or the like) to a remotely located computer 6 such as aPC, lap top, or the like, over communication lines, by modem or wirelessconnection, as shown in the fourth embodiment of FIG. 10. Also, someembodiments may omit the communication station 8 and use a direct modemor wireless connection to the computer 6. In further alternatives,either the medical device module 200 or the telemetered characteristicmonitor transmitter 100 may transmit an alarm to a remotely locateddevice, such as a communication-station, modem or the like to summonhelp. In addition, further embodiments of the characteristic monitor200′ of the medical device module 200 may include the capability forsimultaneous monitoring of multiple sensors. Data transmission may be toother devices or include the capability to receive data or instructionsfrom other medical devices. Preferred embodiments, as shown in FIGS.1-8, use wireless RF frequencies; however, alternative embodiments mayutilize IR, optical, ultrasonic, audible frequencies or the like.Further embodiments may also use a wired connection, as shown in FIG.18.

Preferably, the PDA 10 uses a medical device module 200 that combinesthe characteristic monitor 200′ and character meter 300 into a singledevice, but avoids an actual wired connection to the sensor set 150 byusing a telemetered characteristic monitor transmitter 100. Byseparating the PDA 10 electronics into two separate devices; atelemetered characteristic monitor transmitter 100 (which attaches tothe sensor set 150) and a characteristic monitor 200′, severaladvantages are realized. For instance, the user can more easily concealthe presence of the PDA 10 and the telemetered characteristic monitortransmitter 100, since a wire will not be visible (or cumbersome), withclothing. In also makes it is easier to protect the medical devicemodule 200 with a characteristic monitor 200′, which can be removed fromthe user's body during showers, exercise, sleep or the like. Inaddition, the use of multiple components (e.g., transmitter 100 andmedical device module 200 with a characteristic monitor 200′ with acharacteristic meter) facilitates upgrades or replacements, since onemodule or the other can be modified or replaced without requiringcomplete replacement of the system. Further, the use of multiplecomponents can improve the economics of manufacturing, since somecomponents may require replacement on a more frequent basis, sizingrequirements may be different for each module, there may be differentassembly environment requirements, and modifications can be made withoutaffecting the other components. For instance, the PDA 10 with itsstandard interface and other uses can be mass produced at lower cost.And the medical device module 200 can be made to rigorous medicalstandards at lower cost than a complete device with an interfacecomparable to the PDA 10. This lowers the overall system costs, whichpermits quicker upgrades or design modifications. Thus, manufacturerscan bring new devices and/or options to market in less time and cost andwith less risk.

FIG. 11 is a perspective view of a medical device module 500 thatinterfaces with a telemetered characteristic monitor transmitter 100 inaccordance with a fifth embodiment of the present invention. Thismedical device module 500 includes a characteristic monitor 200′ asdescribed above, and communicates with the telemetered characteristicmonitor transmitter 100 to transfer data signals from a sensor set. Thisembodiment does not include a characteristic meter as described above.Preferably, the communication between the medical device module 500 andtelemetered characteristic monitor transmitter 100 is wireless, asdescribed above. However, in alternative embodiments, a wired connectionsuch as shown in FIG. 18 may be used. In further alternativeembodiments, the medical device module 500 may also just act as ainterface and communication device for the PDA 10 to receive processeddata from the telemetered characteristic monitor transmitter 100, if thetelemetered characteristic monitor transmitter 100 is a fully functionalcharacteristic monitor that includes many of the functions of thecharacteristic monitor 200′ described above.

FIG. 12 is a perspective view of a medical device module 520 thatinterfaces with a characteristic meter 522 in accordance with a sixthembodiment of the present invention. Preferably, the communicationbetween the medical device module 520 and characteristic meter 522 iswireless, as described above. However, in alternative embodiments, awired connection such as shown in FIG. 18 may be used. This embodimentdoes not include a characteristic monitor 200′ or a characteristic meter300 within the medical device module, as described above. Rather, thisembodiment provides an interface with the PDA 10 and communicationcapability between the PDA 10 and the characteristic meter 522.

FIG. 13 is a perspective view of a medical device module 540 thatinterfaces with an infusion device 400, telemetered characteristicmonitor transmitter 100 and a characteristic meter 522 in accordancewith a seventh embodiment of the present invention. This embodiment doesnot include a characteristic meter 300 within the medical device module,as described above. Rather, this embodiment provides an interface withthe PDA 10 and communication capability between the PDA 10 and thetelemetered characteristic monitor transmitter 100, the characteristicmeter 522, and the infusion device 400. This medical device module 540includes a characteristic monitor 200′, and communicates with thetelemetered characteristic monitor transmitter 100 to transfer datasignals from a sensor set and the infusion device 400 as describedabove. Preferably, the communication between the medical device module500 and telemetered characteristic monitor transmitter 100, the infusiondevice 400, and the characteristic meter 522 is wireless, as describedabove. However, in alternative embodiments, a wired connection such asshown in FIG. 18 may be used. In further alternative embodiments, themedical device module 500 may also just act as a interface andcommunication device for the PDA 10 to receive processed data from thetelemetered characteristic monitor transmitter 100, if the telemeteredcharacteristic monitor transmitter 100 is a fully functionalcharacteristic monitor that includes many of the functions of thecharacteristic monitor 200′ described above.

FIG. 14 is a perspective view of a medical device module 560 thatincludes a characteristic meter 300 and interfaces with an infusiondevice 400 in accordance with an eighth embodiment of the presentinvention. This embodiment does not include a characteristic monitor200′ within the medical device module, as described above. Rather, thisembodiment provides an interface with the PDA 10 and communicationcapability between the PDA 10 and the infusion device 400. Preferably,the communication between the medical device module 560 and the infusiondevice 400 is wireless, as described above. However, in alternativeembodiments, a wired connection such as shown in FIG. 18 may be used.

FIG. 15 is a perspective view of a medical device module 580 thatincludes a characteristic meter 300 in accordance with a ninthembodiment of the present invention. This embodiment does not includethe characteristic monitor 200′ as described above. It is primarilyadapted to providing blood glucose test capabilities to the PDA 10.Preferably, the test results and any relevant data input by the user canbe downloaded, or updated program instructions can be uploaded to themedical device module 580 through either a wireless or wired connection.

FIG. 16 is a perspective view of a medical device module 600 thatinterfaces with an infusion device in accordance with a tenth embodimentof the present invention. This embodiment does not include acharacteristic monitor 200′ or a characteristic meter 300 within themedical device module, as described above. Rather, this embodimentprovides an interface with the PDA 10 and communication capabilitybetween the PDA 10 and the infusion device 400. Preferably, thecommunication between the medical device module 600 and the infusiondevice 400 is wireless, as described above. However, in alternativeembodiments, a wired connection such as shown in FIG. 18 may be used.

FIG. 17 is a perspective view of a medical device module 620 thatinterfaces with an implantable medical device 622 in accordance with atenth embodiment of the present invention. Preferred embodiments of theimplantable medical device 622 may be an infusion device, acharacteristic monitor and/or sensor, a pacemaker, a neurostimulator, orthe like. Generally, the devices are completely implanted in the bodytissue 624 of a user. The medical device module 620 acts as an interfaceto the PDA 10 to communicate with and/or receive data from theimplantable medical device 622. This embodiment is not shown with acharacteristic monitor 200′ or characteristic meter 300. However,alternative embodiments could include either or both with acharacteristic monitor 200′ or characteristic meter 300 as well asinterfacing with the implantable medical device.

FIG. 18 is a perspective view of a medical device module 640 thatincludes a input jack 646 for a wired connection with a medical device642 in accordance with an eleventh embodiment of the present invention.The medical device 642 can be any of the devices described herein. Themedical device module 640 is coupled to a cable 644 through an inputjack 646. The medical device 642 is also coupled to the cable 644through an input jack 648 to complete the connection between the medicaldevice module 640 and medical device 642. In particular embodiments, themedical device module 640 may include a modem, or the like, forfacilitating the transfer of data and/or information to the medicaldevice 642. In further embodiments, the input jack 646 is an RS-232port. However, different types of jacks, plugs and connectors may beused. In alternative embodiments, the medical device module 640 may alsoinclude the capability to transfer data and/or information by wirelesscommunication, as described above.

FIG. 19 is a perspective view of a medical device module 660 thatinterfaces with an implantable analyte sensing patch 662 in accordancewith a twelfth embodiment of the present invention. As shown, theimplantable patch 662 is generally implanted under the skin 664 of theuser. However, in alternative embodiments, the implantable patch may beimplanted in other body tissue, as described above, or attached to theskin surface of the user. Preferably, the implantable patch 662 includesa photo-reactive substance or compound 76 that optically changes,fluoresces, or the like, or other suitable compounds that detectchanging properties in the presence of a bodily fluid analyte, such asglucose or the like. The compounds can also be used to detect the levelof an analyte that has been ingested, injected or placed inside thebody, such as marker substances, or the like. For example, possiblecompounds, including but not limited to, produce a fluorescent change inthe presence of a bodily fluid analyte are disclosed in U.S. Pat. No.5,503,770 issued Apr. 2, 1996 to James et al. and entitled “FluorescentCompound Suitable For Use In The Detection Of Saccharides”; U.S. Pat.No. 5,512,246 issued Apr. 30, 1996 to Russell et al. and entitled“Method and Means for Detecting Polyhydroxyl Compounds”; U.S.Provisional Application Ser. No. 60/007,515 to Van Antwerp et al. andentitled “Minimally Invasive Chemically Amplified Optical GlucoseSensor”; and U.S. Pat. No. 6,011,984 to Van Antwerp et al. and entitled“Detection of Biological Molecules Using Chemical Amplification”, all ofwhich are herein incorporated by reference. Other compounds using DonorAcceptor fluorescent techniques may be used, such as disclosed in U.S.Pat. No. 5,628,310 issued May 13, 1997 to Rao et al. and entitled “Method and Apparatus to Perform Trans-cutaneous Analyte Monitoring”;U.S. Pat. No. 5,342,789 issued Aug. 30, 1994 to Chick et al. andentitled “Method and Device for Detecting and Quantifying Glucose inbody Fluids”; and U.S. Pat. No. 5,246,867 issued Sep. 21, 1993 toLakowicz et al. and entitled “Determination and Quantification ofSaccharides by Luminescent Lifetimes and Energy Transfer”, all of whichare herein incorporated by reference. In still further embodiments, themedical device module may interface with the implantable patch usingother communication methods, such as RF or the like.

FIG. 20 is a perspective view of a medical device module 680 thatincludes contacts 684 for interfacing with a medical device 682 inaccordance with a thirteenth embodiment of the present invention. Themedical device 682 can be any of the devices described herein. Themedical device module 680 is coupled to the medical device 642 bycontact 684 being coupled with corresponding contacts 686 on the medicaldevice 642 to complete the connection between the medical device module680 and medical device 682. In particular embodiments, the contacts 684and 686 establish a connection by simply lining up and putting the twodevice together. In other embodiments, the contacts 684 and 686 arephysically coupled together to reduce the likelihood that the connectionwill be accidentally terminated. In other embodiments, the contacts 684are used as electrodes to measure electrical characteristics of theuser. For instance, the contacts may be placed against the skin of theuser to measure pulse, heart rate, sweat effects, or the like. Thisembodiment may utilize a wired or wireless connection to transfer datareceived through the contacts 684 of the medical device monitor 680 toanother medical device, or the like.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within the truescope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims, rather than theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. A medical system, comprising: an externalinfusion device to deliver insulin to a user; a characteristic meter toreceive a blood sample from the user to determine a glucose level of theuser; a sensor set to determine body characteristics on a continuous,near continuous, or intermittent basis, wherein the body characteristicsinclude glucose levels of the user, the sensor set is coupled to atelemetered characteristic monitor transmitter to transmit sensor dataincluding the body characteristics, and wherein the sensor set includesone of an implantable sensor, a subdermal sensor, and a subcutaneoussensor; and a characteristic monitor, including a display having a touchscreen to display the sensor data received from the sensor set, a sensorinterface to wirelessly receive the sensor data from the sensor set viathe telemetered characteristic monitor transmitter, and a microprocessorto program and obtain data from the external infusion device, tocoordinate the sensor data from the sensor set and meter data, includingthe determined glucose level of the user, from the characteristic meterwith the data from the external infusion device, to program and controlthe external infusion device, and to update delivery parameters of theexternal infusion device, wherein the characteristic meter transmits themeter data of the glucose level of the user from the characteristicmeter to the microprocessor of the characteristic monitor.
 2. Themedical system of claim 1, wherein the microprocessor further updatesand programs the telemetered characteristic monitor transmitter.
 3. Themedical system of claim 1, wherein the microprocessor further operatesto download data or upload programming instructions to a computer. 4.The medical system of claim 1, wherein the microprocessor further storesthe sensor data obtained from the sensor set and provides the sensordata to the external infusion device or a computer.
 5. The medicalsystem of claim 1, where the display further displays at least one oftrending information of the body characteristics, graphs of historicaldata, and average body characteristic levels.
 6. The medical system ofclaim 1, wherein the microprocessor processes the sensor data receivedfrom the sensor set to determine when the characteristic meter is to beused to perform calibration of the sensor data.
 7. The medical system ofclaim 1, wherein the characteristic meter utilizes a test strip toanalyze the blood sample to determine the glucose level of the user. 8.A characteristic monitor, comprising: a display having a touch screen todisplay sensor data received from a sensor set, wherein the sensor setdetermines body characteristics on a continuous, near continuous, orintermittent basis, the body characteristics include glucose levels of auser, the sensor set is coupled to a telemetered characteristic monitortransmitter to transmit the sensor data including the bodycharacteristics, and wherein the sensor set includes one of animplantable sensor, a subdermal sensor, and a subcutaneous sensor; asensor interface to wirelessly receive the sensor data from the sensorset via the telemetered characteristic monitor transmitter; and amicroprocessor to program and obtain data from an external infusiondevice that delivers insulin to the user, to coordinate the sensor datafrom the sensor set and meter data from a characteristic meter thatreceives a blood sample from the user to determine a glucose level ofthe user with the data from the external infusion device, to program andcontrol the external infusion device, and to update delivery parametersof the external infusion device, wherein the characteristic metertransmits the meter data of the glucose level of the user from thecharacteristic meter to the microprocessor of the characteristicmonitor.
 9. The characteristic monitor of claim 8, wherein themicroprocessor further updates and programs the telemeteredcharacteristic monitor transmitter.
 10. The characteristic monitor ofclaim 8, wherein the microprocessor further operates to download data orupload programming instructions to a computer.
 11. The characteristicmonitor of claim 8, wherein the microprocessor further stores the sensordata obtained from the sensor set and provides the sensor data to theexternal infusion device or a computer.
 12. The characteristic monitorof claim 8, where the display further displays at least one of trendinginformation of the body characteristics, graphs of historical data, andaverage body characteristic levels.
 13. The characteristic monitor ofclaim 8, wherein the microprocessor processes the sensor data receivedfrom the sensor set to determine when the characteristic meter is to beused to perform calibration of the sensor data.
 14. The characteristicmonitor of claim 8, wherein the characteristic meter utilizes a teststrip to analyze the blood sample to determine the glucose level of theuser.